Regulatory Strategy Lead – FDA Submissions & Lifecycle

The Ritedose Corporation; Columbia (SC); On-site; USD 96,000 - 125,000; Full time

Job summary

The Ritedose Corporation in Columbia, SC is seeking a Regulatory Affairs Manager to lead regulatory strategies for ANDA submissions and provide CDMO support for customer-led submissions (FDA and global). This role ensures compliance and lifecycle management in line with the Director of Regulatory Affairs.

Responsibilities include authoring and editing technical documents, serving as RA lead on teams, and publishing to FDA for lifecycle submissions while guiding junior staff and monitoring

Qualifications

• Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field.
• 5+ years regulatory affairs experience; FDA submission experience required, device/drug-device combo experience preferred.
• Highly detail-oriented with problem-solving and organizational skills.
• Ability to work on complex projects with initiative and minimal guidance.
• Experience with eCTD publishing software and MS Office.

Responsibilities

• Support writing/editing technical documents for internal ANDA and customer-led submissions.
• Act as primary RA contact on project teams to support product development.
• Format, publish, and submit documentation to FDA for initial and lifecycle submissions.
• Respond to FDA queries and deficiencies.
• Develop regulatory strategies for product development, registration, and maintenance across markets.
• Monitor evolving regulations and assess impact on products.
• Oversee adverse event reporting process and ensure compliance with requirements.
• Support due diligence, licensing, and partnerships.

Skills

Detail-oriented

Problem solving

Organization

Communication

Education

Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field

Tools

eCTD publishing software

Electronic document control system

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Acrobat

Job description

The Ritedose Corporation in Columbia, SC is seeking a Regulatory Affairs Manager to lead regulatory strategies for ANDA submissions and provide CDMO support for customer-led submissions (FDA and global). This role ensures compliance and lifecycle management in line with the Director of Regulatory Affairs.

Responsibilities include authoring and editing technical documents, serving as RA lead on teams, and publishing to FDA for lifecycle submissions while guiding junior staff and monitoring